Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
80977–81000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · DCN
Wako Chemicals USA, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · LLZ
Philips Medical Systems North...
Radiology · 76d
Cleared Jan 22, 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · BSZ
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · LLZ
Electromed Intl., Ltd.
Radiology · 53d
Cleared Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708 · DIO
Advantage Diagnostics Corp.
Toxicology · 52d
Cleared Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · LJM
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 20d
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852 · GZF
Advanced Neuromodulation Systems
Neurology · 310d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE...
K000884 · NDZ
Becton Dickinson Biosciences
Microbiology · 305d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · DRT
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Jan 19, 2001
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
K003358 · KPS
Smv America
Radiology · 85d
Cleared Jan 19, 2001
ACROTHERM
K003368 · DWJ
Aquarius Medical Corp.
Cardiovascular · 81d
Cleared Jan 19, 2001
EDTA ROOT CANAL CLEANSER
K003422 · KJJ
Super Glide, Inc.
Dental · 77d
Cleared Jan 19, 2001
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
K003481 · LMC
Codonics, Inc.
Radiology · 71d
Cleared Jan 19, 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484 · LLZ
Scimage, Inc.
Radiology · 71d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 19, 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND...
K003964 · DTK
Cordis Corp.
Cardiovascular · 28d
Cleared Jan 19, 2001
SPLINE DENTAL IMPLANT SYSTEM
K010073 · DZE
Sulzer Calcitek, Inc.
Dental · 10d
Cleared Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · MOS
Image-Guided Neurologics, Inc.
Radiology · 289d
Cleared Jan 18, 2001
PC FLOW +
K001528 · BZG
Spirometrics Medical Equipment Co.
Anesthesiology · 246d
Cleared Jan 18, 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · LYC
Depuyacromed
Dental · 90d
Cleared Jan 18, 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d